INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TRAMAHEXAL ®

        TRMP2

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

TRAMAHEXAL ®
capsules

COMPOSITION:
Each capsule contains
tramadol hydrochloride 50 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 . Other analgesics

PHARMACOLOGICAL ACTION:
Tramadol exerts its analgesic effect centrally, by binding to specific opioid receptors. The release of histamine is not promoted by tramadol. Tramadol is well absorbed following administration and its analgesic effect lasts for up to 9 hours. The mean systemic bioavailability is 68%.
Pharmacokinetics. Tramadol is subject to first pass metabolism thus it is mainly metabolised in the liver (90%). Following the hepatic metabolism, tramadol hydrochloride and its metabolites are almost completely excreted via the renal route (95%). The elimination half life is 5-7 hours.
The terminal half life is likely to be prolonged in patients with impaired renal or hepatic function.
Tramadol hydrochloride crosses the blood brain and placental barriers. Only very small amounts are excreted in the breast milk unchanged or as metabolite M1.

INDICATIONS:
Short term management of moderate to moderately severe pain.

CONTRA-INDICATIONS:
Cases of acute intoxication, with alcohol, hypnotics or other medicines acting on the central nervous system (CNS).
Safety during pregnancy and lactation has not been established.
Patient with known hypersensitivity to tramadol or other opioids.
Patients with severe respiratory depression.
TramaHexal® should not be given to patients with respiratory depression , especially in the presence of cyanosis and excessive bronchial secretions.
Patients with increased intracranial pressure or CNS depression due to head injury or cerebral disease.
Combination with monoamine oxidase inhibitors (see Interactions).

WARNINGS:
Tramadol is likely to intensify and prolong the CNS effects of CNS depressant medicines.
Patients should be warned not to operate dangerous machinery or drive a vehicle.
Tramadol does not supress morphine withdrawal symptoms.
It may be necessary to adjust the dose when administering tramadol to patients suffering from impaired renal or hepatic function.
Although TramaHexal® has a low dependence potential, tolerance, psychic and physical dependence of the morphine type (µ opioid) may develop with long term use. The medicine has been associated with craving, drug seeking behaviour and tolerance development. Cases of abuse and dependence on TramaHexal® have been reported. TramaHexal® should not be used in opioid dependent patients. TramaHexal® can re-instate physical dependence in patients that have been previously dependent or chronically using other opioids. In patients with a tendancy to drug abuse, a history of drug dependence, or are chronically using opioids, treatment with TramaHexal® is not recommended.
Seizures have been reported in patients receiving TramaHexal® at doses within the recommended dosage range. The risk of seizures is enhanced in patients exceeding the recommended dose, or in patients taking tricyclic antidepressants or other tricyclic compounds. The risk of seizures may also be increased in patients with epilepsy, a history of seizures or in patients with a recognised risk of seizures e.g. drug and alcohol withdrawal, intracranial infections, head trauma, metabolic disorders and naloxone administration with TramaHexal® overdosage.

DOSAGE AND DIRECTIONS FOR USE:
Starting dose - adults and adolescents over 14 years of age: 1 capsule.
If desired analgesia is not achieved within 30 to 60 minutes, a second capsule may be taken.
Maximum daily dose (in general): 400 mg tramadol (i.e. 8 capsules).
Note : Dosage should be adjusted according to the intensity of the pain and the patient’s response to analgesia.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The following have been reported : sedation , drowsiness, dizziness, nausea, vomiting, dry mouth, sweating, heartburn, constipation, fatigue, confusion, hallucinations, skin rashes, bradycardia, tachycardia, flushing, bronchospasm, angioedema, syncope, anaphylaxis, anaphylactoid reactions.
Postural hypotension or cardiovascular collapse.
Tramadol has a low potential for dependence (see warnings).
Tramadol should not be used for the treatment of minor pain.
TramaHexal® should be used with caution in patients with severe impairment of hepatic or renal function and in patients prone to convulsive disorders or in shock.
Seizures have been reported (see warnings).
Interactions:
Other CNS depressants - intensification and prolongation of CNS effects.
Tranquillisers - may produce favourable effects on pain sensation and management.
Should not be given concomitantly with MAO inhibitors or within 14 days of discontinuation of it as potentiation of serotenergic and noradrenergic effects results.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
(See Side Effects and Special Precautions)
Respiratory depression, may be treated with a pure opiate antagonist (Naloxone).
Treatment of restlessness and/or convulsions is symptomatic and supportive (benzodiazepines/barbiturates).
TramaHexal is minimally eliminated from the serum by haemodialysis or haemofiltration, therefore it is not suitable for detoxification treatment.

IDENTIFICATION:
Snap-fit, green cap and yellow body hard gelatine capsules (size 3), containing a white to off-white odourless powder.

PRESENTATION:
White opaque polypropylene/Aluminium blisters. 10 capsules per blister strip.
20 or 100 capsules per carton.
White, opaque securitainers containing 20 or 100 capsules.

STORAGE INSTRUCTION
Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
32/2.9/0652

NAME AND BUSINESS OF ADDRESS OF THE APPLICANT
Hexal Pharma (SA) (Pty) Ltd
Unit A, 10 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT
February 2000

        TRMP2

Updated on this site: February 2004
Source: Community Pharmacy

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